The Recall Desk
CriticalFDA (Drugs)·D-0211-2017·Announced 2016-12-28

Guardian Pharmacy Recalls Lidocaine Syringes Due to Failed Sterility Test

Guardian Pharmacy Services is recalling 180 pre-filled Lidocaine HCL/Sodium Bicarb syringes because a sterility test failed. The product was distributed to two medical facilities in Texas.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which meets the criteria for a Critical severity score.

Plain-English summary

Guardian Pharmacy Services is recalling 180 units of Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe. The recall is due to a failed sterility test result, which indicates the product may not be sterile.

The affected product is identified by Lot # 50699:00 and has an expiration date of 10/04/16. The recall is classified as Class I by the FDA. The product was distributed to two medical facilities in Texas.

Healthcare providers and patients should stop using the affected syringes immediately and contact Guardian Pharmacy Services for instructions on how to return the product.

The recalled product

Product
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Manufacturer
Guardian Pharmacy Services
Category
Drug — Injectable
Hazard
Affected units
180

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 50699:00
  • Exp 10/04/16

Distribution

Distributed in 1 state:

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